Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial (OPTIMAL)

This study has been completed.

Sponsor:

NICHDPelvic Floor Disorders Network

ClinicalTrials.gov Identifier:

NCT00597935

First Posted: January 18, 2008

Last Update Posted: September 30, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Collaborators:

Office of Research on Women's Health (ORWH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Stage 2 to 4 prolapse

Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2)

Vaginal bulge symptoms as indicated by an affirmative response to either questions on the PFDI

Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.

Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale

Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months

A TVT is planned to treat stress urinary incontinence.

A PMT visit can be performed at least 2 weeks and not more than 4 weeks before surgery.

Available for 24-months of follow-up.

Able to complete study assessments, per clinician judgment

Able and willing to provide written informed consent

Exclusion Criteria:

Contraindication to SSLF, ULS, or TVT in the opinion of the treating surgeon.

History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)

Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.

History of previous synthetic sling procedure for stress incontinence.

Previous adverse reaction to synthetic mesh.

Urethral diverticulum, current or previous (i.e., repaired)

History of femoral to femoral bypass.

Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.

History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.

Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597935

Locations

United States, Alabama

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233-7333

United States, California

Kaiser Permanente Bellflower

Bellflower, California, United States, 90706

University of California, San Diego Medical Center

La Jolla, California, United States, 92037

Kaiser Permanente

San Diego, California, United States, 92120

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75390

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

NICHDPelvic Floor Disorders Network

Office of Research on Women's Health (ORWH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)